510(k) · Cleared
ClearedPerioglas Plus - Settable Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novabone Products, LLC · LYC Bone Grafting Material, Synthetic
Cleared on Nov 5, 2003 as substantially equivalent to K992416 (Usbiomaterials Corp., 1999) and 3 other predicates after a 215-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Nov 5, 2003
- Review
- 215 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K941780 (1995). 8 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK941780 Orthovita BiogranOrthovita Co. · 1995
- 1 generation backK962494 Perioglas - Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1996
- This deviceK031073 Perioglas Plus - Settable Bone Graft SubstituteNovabone Products, LLC · 2003
- Descendant · cites it directly · 0 of its ownK042707 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042707Grafton Plus DBM PasteOsteotech, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941780 | Orthovita Biogran | Orthovita Co. | 1995 | — |
| −1 | K962494 | Perioglas - Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1996 | — |
| 0 (this device) | K031073 | Perioglas Plus - Settable Bone Graft Substitute | Novabone Products, LLC | 2003 | — |
| +1 | K042707 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 13 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 1…erial Classification Name: Unknown 3. Legally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K992416, K962492, K9301151 Predicate #2: CAPSET Calcium Sulfate Bone Graft Plaste… | 1999 |
| * | K962494 | Perioglas - Bioglass Bone Graft Particulate Our reading of the summary gave K962492, FDA’s number for Silenzio Plus Continuous Positive Airway Pressure System (Nidek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PerioGlas - Synthetic Bone Graft Particulate”. | 1996 |
| * | K930115 | PerioglassSummary page 1…Legally Marketed Predicate Device: Predicate #1: PerioGlas - Synthetic Bone Graft Particulate [K992416, K962492, K9301151 Predicate #2: CAPSET Calcium Sulfate Bone Graft Plaster [K955096] 4. Device Description Per… | 1993 |
| * | K955096 | Capset Calcium Sulfate Bone Graft PlasterSummary page 1…hetic Bone Graft Particulate [K992416, K962492, K9301151 Predicate #2: CAPSET Calcium Sulfate Bone Graft Plaster [K955096] 4. Device Description PerioGlas Plus is a synthetic resorbable osteoconductive bone graft substitute co… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042707 | Grafton Plus DBM Paste | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K042707 (Osteotech, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K992416.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
What is it indicated for?
PerioGlas Plus - Settable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PerioGlas Plus is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects…
Read the full statement (106 words)
PerioGlas Plus - Settable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PerioGlas Plus is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); craniofacial augmentation; sinus lifts; cystic defects. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031073: Perioglas Plus - Settable Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031073
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026